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Serological Response to Retreatment of Serofast Early Syphilis Cases With Benzathine Penicillin

Primary Purpose

Syphilis

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
benzathine penicillin
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Syphilis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Early Syphilis Cases Determined to Be Serofast at 6 Months after Initial Treatment

Exclusion Criteria:

  • Human immunodeficiency virus (HIV)-infected
  • Baseline serology showed a nonreactive RPR test
  • follow-up is inadequate
  • Allergic to penicillin
  • Pregnant woman

Sites / Locations

  • Department of Dermatology and Venereology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Retreatment group

Control group

Arm Description

Serofast early syphilis cases retreated with three doses benzathine penicillin

Absence of any retreatment

Outcomes

Primary Outcome Measures

Rapid plasma regain titer

Secondary Outcome Measures

Full Information

First Posted
August 22, 2016
Last Updated
November 15, 2018
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02884115
Brief Title
Serological Response to Retreatment of Serofast Early Syphilis Cases With Benzathine Penicillin
Official Title
Randomized, Clinical Trial to Compare the Serological Response Rates of Serofast Early Syphilis Cases Retreated With Three Doses Benzathine Penicillin and Absence of Any Retreatment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

5. Study Description

Brief Summary
A continuing challenge to determining the response to treatment of early syphilis (primary, secondary, early latent syphilis) is exemplified by the substantial proportion of patients who fail to achieve serological cure and remain serofast. Although retreatment is often done in clinical practice, optimal management remains uncertain due to the paucity of data regarding serological response to retreatment and long-term outcomes. Furthermore, the investigators cannot rule out that the gradually increasing seroreversion/serological cure rates may have been due to the natural decline in rapid plasma regain (RPR) titers after initial therapy, rather than due to the additional dose of benzathine penicillin. Thus, the investigators would like to conduct a clinical trial to compare the serological response rates of serofast early syphilis cases retreated with three doses benzathine penicillin and absence of any retreatment (control group).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syphilis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Retreatment group
Arm Type
Active Comparator
Arm Description
Serofast early syphilis cases retreated with three doses benzathine penicillin
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Absence of any retreatment
Intervention Type
Drug
Intervention Name(s)
benzathine penicillin
Primary Outcome Measure Information:
Title
Rapid plasma regain titer
Time Frame
6 months after retreatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Early Syphilis Cases Determined to Be Serofast at 6 Months after Initial Treatment Exclusion Criteria: Human immunodeficiency virus (HIV)-infected Baseline serology showed a nonreactive RPR test follow-up is inadequate Allergic to penicillin Pregnant woman
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Li, M.D.
Phone
86-010-69151504
Email
lijun35@hotmail.com
Facility Information:
Facility Name
Department of Dermatology and Venereology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Li, M.D.
Phone
86-010-69151504
Email
lijun35@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Serological Response to Retreatment of Serofast Early Syphilis Cases With Benzathine Penicillin

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